MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number AR40E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Blurred Vision (2137); Visual Impairment (2138)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.

Event Description

It was reported that an intraocular lens (iol) had malfunctioned (came undone/loose) in patient's left eye.Further information was provided and the patient reported the lens became detached and was located in the web of his eye.The patient started seeing like looking through thick plastic or heavy smoke.In a (b)(6) 2019 examination, the patient had reduced visual acuity (va) in left eye.Dilated fundus exam (dfe) showed iol torn completely away at 12 and 2 o'clock positions.Best corrected visual acuity (bcva) 20/400.The patient was referred to a retina specialist for dislocated iol.In (b)(6) 2019, the patient had a retinal evaluation.Patient states that in june he noticed he could not see any longer out of his left eye.The patient complained of blurred vision, pain, and floaters.The patient denied any noticeable changes to va.The timing is described as constant, quality is unchanging, and severity is described as stable.The retina specialist diagnosed as a subluxation of lens in left eye and the iol is in the vitreous.The examination also revealed episcleritis.Therefore, the lens was explanted and replaced with another lens.No additional information was provided.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10298873
• MDR Text Key: 199993853
• Report Number: 2648035-2020-00516
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502093
• UDI-Public: (01)05050474502093(17)161223
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2016
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR